Summary of the position:
The In-House CRA supports the clinical trial sites in conducting the clinical trial and performs tasks related to study support and site management activities. The current document describes all the activities and responsibilities for the In-House CRA position.

Essential functions:
• Accurately maintain the Clinical Trial Master System (CTMS) by entering and updating study and site status and data as per the project timelines, as assigned.
• Manage, track, and review all site regulatory documents.
• Conducts monthly quality reviews of the Trial Master File (TMF) to maintain inspection readiness, addressing delinquencies, as necessary.
• May assist with the development, review, file and/or track study documents, including, ICFs, Case Report Forms (CRFs) and CRF Completion Guidelines, Clinical Monitoring Plan and Research Specimen Manuals.
• Completes Institutional Review Board submissions for post start up documentations that require regulatory review/approvals.
• May act as the primary contact and liaison with investigative sites during study maintenance and when assigned, site start up activities, with responsibility for collection of the required investigator and regulatory documents to ensure EC applications are made within the timelines agreed with project management and Clinical SSU team.
• Perform remote management to ensure protocol and regulatory compliance and effectively resolve site related issues.
• Proactively identify, manage, and escalate issues related to study delivery, triaging, and coordinating communication and resolution efforts
• Communicates with investigative sites and internal team members to forecast timelines for site activation and ensure all activation requirements are met.
• Assess adequacy of potential clinical investigators and clinical trial sites.
• Maintain tracking and reporting logs for site management activities.
• Manage, track, and review all site regulatory documents
• Train clinical investigators and site personnel on clinical trial protocol and regulatory requirements.
• Act as a primary contact with onsite CRAs, Contract Research Organizations (CROs), and assigned clinical trial sites.
• Assist with management of clinical trial supplies, including Investigational Product, laboratory kits, etc.
• Performs remote monitoring activities as agreed.
• Assist with management of clinical trial safety and efficacy issues, including review and follow-up of Serious Adverse Event reports.
• May perform data listings review and generate of data queries.
• Train and mentor junior-level team members
• Utilize all study systems, software, shared documents, folders for effective site management and study communication, both internally and externally
• Adaptability of different study designs and methods.
• Perform all duties and responsibilities in accordance with CFR, GCP/ICH Guidelines, SOPs, Training Guides, and other applicable guidelines.
• All other duties as assigned.

Knowledge, Skills, and Abilities:
• Understanding of the conduct of clinical trials, related systems, and procedures, and guidance and regulations.
• Knowledge of ICH / GCP regulations
• Previous experience with database and clinical management systems.
• Ability to prioritize and manage multiple tasks with demonstrated ability to meet deadlines.
• Possess an understanding of medical and clinical research terminology.
• Ability to write clearly and succinctly; must be able to accurately record meeting minutes and action items.
• Driven self-starter with the ability to begin tasks independently and complete tasks without supervision.
• Must have excellent interpersonal and communication skills and demonstrate the ability to work successfully in a team environment.
• Demonstrated effective organizational skills and strong attention to detail.
• Ability to establish and maintain effective working relationships with coworkers, managers, and clients.
• Customer-service focused on approach to work, both internally and externally

Position Requirements
Education:
• Bachelor’s degree or its international equivalent in Health, Behavioral, Life or Social Sciences or other fields related to international/ human development.

Required Job-related Experience:
• 1 – 2 years of related experience in regulatory affairs, clinical research, or clinical operations environment.
• Knowledge of ICH and local regulatory authority drug research and development regulations preferred.
• Proficiency in Microsoft Office and spreadsheets
• Articulate, professional, and able to communicate in a clear, positive fashion with clients and staff.
• Ability to work independently without direction.
• Ability to adapt to fast paced environment requiring flexibility and task prioritization.
• Must be able to read, write and speak fluent English.

Additional Eligibility Qualifications:
• Experience with Trial Master File (TMF)
• Experience with Clinical Trial Management Systems (CTMS)

Preferences:
• Related prior work experience
Special Position Requirements: None

Physical Expectations:
• Typical office environment. Ability to sit and stand for extended periods of time; ability to lift 5-50 lbs.

Travel Requirements:
Expected travel time is up to 20% for this position.

Work Hours: 8

Experience in Months: 12

Level of Education: Bachelor Degree